Search Results

The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations.

AMP amphetamines 1000 ng/ml
COC cocaine 300 ng/ml
MOR opiates 300 ng/ml
PCP phencyclidine 25 ng/ml
THC cannabinoids 50 ng/ml

FINGERPRINT Drug Screening Device™ test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmed analytical result. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "FINGERPRINT Drug Screening Device™". It describes the intended use and includes a table of drug analytes and their respective cutoff concentrations. However, it does not include specific information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory communication confirming substantial equivalence, not a scientific study report.

Ask a specific question about this device